Frequently asked questions
Regulation governance and safety
Compliance, cyber security and classification
GETTING STARTED
The Pharma Printer is made for hospital pharmacies, retail pharmacies, pharma industry, veterinarians and at point of care by pharmacists.
From our webstore or via contacting sales.
You can order GMP manufactured Excipient Bases from our webstore or via contacting sales.
The delivery time is approx 6-8 weeks, depending on order volume.
Our technology is effective for both human and veterinary medicine.
Yes, this is possible from our webstore or via contacting sales.
Our solution is easy to use and it takes only an hour to learn how to use the Pharma Printer with quality control tools.
We offer several pricing options for our technology, depending on your situation. You can either purchase the equipment, rent it or agree on a model of minimum order quantities of our Excipient Bases. We do not charge for formulation development. Instead customers can subsribe to our formulation library.
Would you like a quote? Please contact us and we are happy to help you forward.
MANUFACTURING
It takes 1-3 seconds to print one dose, depending on dose of the tablet.
It is possible to flexibly print from one to several dozens of tablets in one printing round, depending on the size of the tablets. You can dose around 1000 doses/hour on average with quality control. If you do not need mass uniformity the process is faster.
We provide validated cleaning protocols for each formulation to avoid cross-contamination. Cleaning is fast. We also provide single use syringes to avoid cross-contamination.
We have detailed but simple, validated cleaning protocols for the Pharma Printer. All parts are easy to clean and it shouldn’t take more than 10 minutes to finalize between different APIs.
Yes, it is possible to dose into blisters, molds or vials.
We provide templates for unit dosing or pharmacies can use their own.
You can use the Compounding System Solution to dose chewable tablets, suppositories or liquids - all with one device and no need to change extruder.
You can dose API’s ready to be used with our Excipient Bases or your own. We provide a formulation library for API’s that our customers are compounding today, for example for paediatric use (propranolol, hydrocortisone, metoprolol, clopidrogel etc). These include stability data and dissolution profiles for instance. We have over 200 APIs on our list.
We want to serve pharmacies with all their compounding needs i.e. provide printable inks for APIs that they manufacture the most. We are not charging for development work of API’s. If you want to have a list of our current APIs, please contact us.
We have an integrated analytical scale to measure individual weights of the dosage forms and in-process NIR control to evaluate the blend uniformity of the Pharma Inks prepared at the pharmacy. Documentation and batch record is available in our formulation library.
Yes, the CuraBlend has a PZN number which is 19290012.
REGULATION, GOVERNANCE AND SAFETY
CurifyLabs is compliant with existing regulations for pharmacy compounding. We provide the following:
- Our quality management system is compliant with ISO 13485
- CE marked for IEC 61010-1 (classified as laboratory equipment)
- We provide quality documentation for printable pharma ink bases which can be used with several API’s. As our customer you have access to all necessary quality documentation (stability, dissolution, batch records, cleaning protocols etc)
- All raw materials are compliant with the European pharmacopeia.
- Excipient Bases are GMP manufactured and classified as medicinal intermediate product.
- We offer in-process quality control of mass and blend uniformity.
Pharma Printer does not act as a Internet server in any case. It cannot be accessed directly from the Internet. CurifyLabs also recommends installation behind a company firewall.
CurifyLabs’ Web App is regularly tested for cyber security by a 3rd party audit company. Customers can request a summary from the latest audit.
Pharma Printer does not process or store patient data. To use the printer, the end user has to have an account to the Web App and for that an email address of the pharmacy user is needed. Storing the email address is GDPR compliant.
Pharma Printer is not a medical device. It is a laboratory equipment comparable to, for example, HPLC.
GENERAL
Pharma Printer requires cable (LAN) connection to access the Internet.
The Pharma Printer is intended for use in busy pharmacies, meaning that our user interface is easy to use and fast to handle. We also offer additional research features for customers who want to do research.
Pharma Printer is designed and manufactured in European Union.
We share information about the bases in our customer portal. Peadiatric formulations have been made so that they are compliant with peaditric patient safety recommendations.
You can use your own bases if you want to. In order to ensure the best dosing experience and utilize our extensive formulation library and GMP manufactured Excipient Bases we recommend using inks that we have validated with the Compounding System Solution. These also include stability data, dissolution profiles and other required documentation for regulators.
Our Excipient Bases are based on over a decade of academic research and built by over 50 pharmacists in Europe.
We offer 3 service plans for your convenience.